Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00698802
First received: June 16, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: EX1000
Drug: biphasic human insulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Fructosamine [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • FPG [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • 4-point SMPG profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events (including injection site reactions) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Laboratory safety parameters (haematology, biochemistry and lipids) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Physical examination and vital signs [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Total daily insulin dosages [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: EX1000
Treat-to-target titration scheme, s.c. injection
Active Comparator: B Drug: biphasic human insulin
Treat-to-target titration scheme, s.c. injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
  • Body Mass Index (BMI) less than or equal to 40.0 kg/m2
  • HbA1c less than or equal to 9.5%
  • FPG (SMPG) less than or equal to 12 mmol/L

Exclusion Criteria:

  • Treatment with more than 1IU/kg insulin daily
  • Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial products or related products
  • Receipt of any investigational drug within one month prior to this trial
  • Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698802

Locations
India
Vijayawada, India, 520002
South Africa
Johannesburg, Gauteng, South Africa, 2193
United Arab Emirates
Abu Dhabi, United Arab Emirates, 51900
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Kaa Meier Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00698802     History of Changes
Other Study ID Numbers: EX1000-1919
Study First Received: June 16, 2008
Last Updated: September 5, 2012
Health Authority: India: Ministry of Health
South Africa: Medicines Control Council
United Arab Emirates: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014